BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

    Recall: Z-1834-2026 · Reported April 29, 2026

    Enforcement

    Recall Number
    Z-1834-2026
    Event ID
    98599
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2026
    Initiation Date
    February 25, 2026
    Classification Date
    April 17, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

    Reason

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Code Info

    1) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23KBL880; 2) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 24ABA125; 3) DYNJQ0505M, UDI-DI: 10889942846900(each), 40889942846901(case), Lot Number: 23IBA898; 4) DYNJT2021G, UDI-DI: 10193489608816(each), 40193489608817(case), Lot Number: 24CMH245; 5) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25LBQ639; 6) DYNJ31377B, UDI-DI: 10889942106691(each), 40889942106692(case), Lot Number: 25GBF384; 7) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25DBQ486; 8) DYNJ51279, UDI-DI: 10889942145300(each), 40889942145301(case), Lot Number: 25CBT538; 9) DYNJ52447, UDI-DI: 10889942279777(each), 40889942279778(case), Lot Number: 25FMA232; 10) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25ILA917; 11) DYNJ53369C, UDI-DI: 10193489651331(each), 40193489651332(case), Lot Number: 25FLA554; 12) DYNJ53591A, UDI-DI: 10889942592371(each), 40889942592372(case), Lot Number: 25FBA222; 13) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21JBN533; 14) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBM563; 15) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21KBQ110; 16) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 21LBI454; 17) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23DMF559; 18) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23EMB053; 19) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23FME913; 20) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23JME012; 21) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24BMK272; 22) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043; 23) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24CMK043Z; 24) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24DMJ156; 25) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24FMI064; 26) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24HMB643; 27) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 24JME212; 28) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 23HME551; 29) DYNJ57516, UDI-DI: 10889942748426(each), 40889942748427(case), Lot Number: 25DMB495; 30) DYNJ58722A, UDI-DI: 10193489329698(each), 40193489329699(case), Lot Number: 25GBS720; 31) DYNJ62742, UDI-DI: 10193489685923(each), 40193489685924(case), Lot Number: 24KBE607; 32) DYNJ67876, UDI-DI: 10193489449198(each), 40193489449199(case), Lot Number: 25KBP615; 33) VASC1170A, UDI-DI: 10193489774863(each), 40193489774864(case), Lot Number: 23GMC436

    Distribution

    US Nationwide distribution.

    Quantity

    3183 units